The pharmaceutical companies must go through a number of loops to get their products approved by the FDA. This week at the Food and Drug Administration’s campus in Silver Spring, Maryland, Drug makers, insurance companies, and lawyers filled a room to listen to public hearings to change those rules. This is no trifling matter; companies spend $27 billion each year to market their products to the public.
Dr. Robert Califf, the commissioner of the FDA, said that the reevaluation of the regulations is to make sure that the system “best protects and promotes the public health and the well-being of patients.” There are two different sides for the argument on loosening rules for FDA drug approval. Companies want looser restrictions in order to bring their products to market more easily. Companies use phrases like “stifling innovation” to describe the effects of having such harsh restrictions on drug approval.
However, on the other hand patients believe that a loosening of the rule would be disastrous for the industry and potentially put their health at risk by allowing a wider number of drugs that may not be safe get approval from the FDA. Even with the current strict regulations, there are a number of patients who are negatively effected by FDA approved drugs.
The Current Law of the (Pharmaceutical) Land In order to gain approval from the FDA, a company must not only spend extreme amounts of money, but also time. It beings with a testing process which goes through many phases and then only after positive results and sound data does the information get sent to the FDA to determine whether the drug works or not.
When the company gets approval (if it does), it can then begin to market and sell the product to the public. However, doctors do not need to limit their prescriptions to only FDA approved drugs. Doctors can use any drug they think will work for a patient, even if it is not approved. When a doctor prescribes a drug that is not approved, it is called an ‘off-label’ prescription. The Problems with ‘Off-Label’ Medicines
Many people claim that using ‘off-label’ drugs can be both harmful and possibly expose patients to risky treatments. These critics also claim that if the FDA rules were to be loosened even further, then it could lead to waste, and even more danger to the patients. The pharmaceutical companies can be seen using terms such as “emerging therapies” or “advancement in clinical practice” to describe drugs that have not been approved by the FDA. Loosening the rules and regulations would “undermine the integrity of the FDA drug approval process,” said Sarah Chistopherson of the National Women’s Health Network.
Another possible issue is that if more drugs are allowed to be marketed to the public due to looser regulations, patients will go for the drugs that have the most media traction and not the ones that are the most effective. The FDA will be considering changes to its regulations and receive suggestions by January. At that point, the agency will decide if there is enough evidence and positive benefits to change the rules that govern marketing of drugs and the use of ‘off-label’ drugs.